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A Brief Educational Intervention to Improve Traumatic Brain Injury (TBI) Screening Outcomes

A Brief Educational Intervention to Improve TBI Screening Outcomes

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01558791
Acronym
TBI
Enrollment
1236
Registered
2012-03-20
Start date
2011-09-30
Completion date
2013-01-31
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI

Keywords

PTSD, patient education handout

Brief summary

This research study is designed to learn about Veterans' understanding of mild TBI (traumatic brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to one of the study-related clinics for TBI screening will be invited to participate. An educational handout on TBI will be given to half of the participants along with their TBI screening. The other half of the participants will have the usual TBI screening without the educational handout. Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire. The questionnaire will ask: * About the individual: such as gender and branch of service * About what happened during the TBI screening: such as whether the Veteran had a chance to ask the provider any questions * About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are long lasting Veterans who receive the educational handout will be asked specific questions about the handout and its information.

Detailed description

OBJECTIVE/HYPOTHESIS: The investigators propose to develop an educational handout on mild traumatic brain injury (mTBI) and to evaluate whether this brief, educational intervention improves knowledge and understanding of TBI and the screening results. The long-term goal is to promote expectations for a positive recovery in Veterans with mTBI. The specific aim is to evaluate the effect of the intervention on Veterans' knowledge and illness perceptions regarding TBI. Hypotheses are as follows: 1. Veterans who receive the educational intervention will have improved knowledge and understanding of TBI and the meaning of a positive TBI screen compared to Veterans who undergo screening as usual. 2. Veterans who screen positive for TBI and receive the educational intervention will have less negative illness perceptions regarding TBI compared to Veterans who screen positive in the control group. Secondary analyses are to identify clinic-level barriers and facilitators to incorporation of the educational handout into the clinical encounter. RESEARCH PLAN: The investigators will compare 2 groups of Veterans (N = 1500), half of whom are screened as usual and half of whom receive the educational intervention. Participants will be Veterans from 4 VA post-deployment clinics in Bay Pines, FL; Hampton, VA; Providence, RI; and Tampa, FL. The recruitment portion of the study will last 24 weeks at each site. The first 12 weeks of the study, all OEF/OIF Veterans that are screened for TBI will be enrolled into the screening as usual control group. The following 12 weeks all OEF/OIF Veterans screened for TBI will be enrolled into the intervention group. The investigators anticipate enrolling 750 Veterans in each group. METHODOLOGY: All OEF/OIF Veterans screened for TBI in the 4 identified post-deployment clinics during the study period will be eligible for inclusion in the study. The primary outcome is knowledge gained about mTBI and illness perception. All participants will be given an instrument with questions on demographics and TBI knowledge and perceptions. Participants who receive the educational handout will be asked for additional feedback. The investigators will examine the effect of the intervention on the number of correct responses to the knowledge items as well as the rates of correct answers to each individual knowledge item. Further, the investigators will examine the effect of the intervention on each of the illness perception scores.

Interventions

OTHERTBI handout

The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All OEF/OIF Veterans screened for TBI at the designated clinic at 1 of the 4 study sites (during the 6 months of recruitment) will be eligible.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
mTBI QuestionnaireOne day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.
Illness Perception - Current SymptomsOne day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.
Illness Perception - Duration of SymptomsOne day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.

Secondary

MeasureTime frameDescription
Feasibility QuestionnaireOne month- Providers complete a questionnaire within 1 month after data collection ends for the site.A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.

Countries

United States

Participant flow

Participants by arm

ArmCount
Screened as Usual
Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention.
607
TBI Handout
Participants will be given the TBI handout (educational intervention) along with the usual TBI screen. TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover.
629
Total1,236

Baseline characteristics

CharacteristicScreened as UsualTBI HandoutTotal
Age, Customized
20-29 years
287 participants306 participants593 participants
Age, Customized
<20 years
0 participants1 participants1 participants
Age, Customized
30-39 years
152 participants158 participants310 participants
Age, Customized
40-49 years
123 participants119 participants242 participants
Age, Customized
50-59 years
39 participants38 participants77 participants
Age, Customized
60+ years
5 participants1 participants6 participants
Employment
Full-time
178 participants197 participants375 participants
Employment
Part-time
37 participants27 participants64 participants
Employment
Retired
69 participants58 participants127 participants
Employment
Student
150 participants149 participants299 participants
Employment
Unemployed
170 participants191 participants361 participants
Marital status
Divorced
117 participants114 participants231 participants
Marital status
Married
269 participants300 participants569 participants
Marital status
Never married
171 participants161 participants332 participants
Marital status
Separated
42 participants44 participants86 participants
Marital status
Widowed
2 participants3 participants5 participants
Reported PTSD diagnosis
No
440 participants469 participants909 participants
Reported PTSD diagnosis
Yes
152 participants146 participants298 participants
Service Branch
Air Force
524 participants543 participants1067 participants
Service Branch
Army
346 participants335 participants681 participants
Service Branch
Coast Guard
599 participants617 participants1216 participants
Service Branch
Marine Corps
508 participants533 participants1041 participants
Service Branch
National Guard
529 participants571 participants1100 participants
Service Branch
Navy
463 participants477 participants940 participants
Service Branch
Reserves
570 participants581 participants1151 participants
Service connection
No
305 participants277 participants582 participants
Service connection
Yes
278 participants311 participants589 participants
Sex/Gender, Customized
Female
91 participants99 participants190 participants
Sex/Gender, Customized
Male
494 participants483 participants977 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Illness Perception - Current Symptoms

Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.

Time frame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.

Population: All veterans who accepted questionnaire

ArmMeasureValue (MEAN)Dispersion
Arm 1Illness Perception - Current Symptoms6.92 units on a scaleStandard Deviation 2.46
Arm 2Illness Perception - Current Symptoms6.79 units on a scaleStandard Deviation 2.4
Primary

Illness Perception - Duration of Symptoms

Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.

Time frame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.

Population: All veterans screened who accepted questionnaire

ArmMeasureValue (MEAN)Dispersion
Arm 1Illness Perception - Duration of Symptoms7.59 units on a scaleStandard Deviation 2.55
Arm 2Illness Perception - Duration of Symptoms7.61 units on a scaleStandard Deviation 2.5
Primary

mTBI Questionnaire

The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.

Time frame: One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.

Population: All veterans screened who accepted the questionnaire.

ArmMeasureValue (MEAN)Dispersion
Arm 1mTBI Questionnaire5.38 correct answers out of 10Standard Deviation 2.94
Arm 2mTBI Questionnaire7.52 correct answers out of 10Standard Deviation 2.65
Secondary

Feasibility Questionnaire

A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.

Time frame: One month- Providers complete a questionnaire within 1 month after data collection ends for the site.

Population: PI and project staff no longer have access to this data to report results.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026